Robert Harshbarger
Jr. of Kingsport, TN pleaded guilty to charges he replaced FDA-approved iron
sucrose for use in kidney dialysis with
cheap foreign versions of the drug. Patients
in Kansas were unwittingly exposed to the misbranded drugs.

Harshbarger was originally charged by the FDA in March
2012. In the indictment, he was charged
with one count of selling misbranded drugs, one count of mail fraud and five
counts of health care fraud, for substituting cheap Chinese-made iron sucrose
for the FDA approved Venofer he claimed to be filling prescriptions with,reported the Department of Justice at the time of Harshbarger’s indictment.

Robert Harshbarger
Jr. of Kingsport, TN pleaded guilty to charges he replaced FDA-approved iron
sucrose for use in kidney dialysis with
unapproved foreign versions of the drug. Patients
in Kansas were unwittingly exposed to the misbranded drugs.

Harshbarger was originally charged by the FDA in March
2012. In the indictment, he was charged
with one count of selling misbranded drugs, one count of mail fraud and five
counts of health care fraud, for substituting unapproved Chinese-made iron sucrose
for the FDA approved Venofer he claimed to be filling prescriptions with,reported the Department of Justice at the time of Harshbarger’s indictment.

Kansas First News reports that Harshbarger pleaded guilty to
the charges. According to their report,
several patients of Kansas Dialysis Services, L.C were treated with the
misbranded dialysis drugs. None have
reported problems, but the FDA warns that patients are at risk since
the iron sucrose had not passed through the FDA approval process. As U.S. Attorney Barry Grissom stated in the
indictment, “The FDA cannot assure the safety and effectiveness of products
that are not FDA approved and come from unknown sources and foreign locations,
or that may not have been manufactured under proper conditions. These unknowns
put patients’ health at risk because of uncertainty concerning the product’s
content, purity and source.”

According to the Times News, Harshbarger is scheduled to be sentenced
on November 4th, and faces a possible 48 months in federal
prison. Additionally he may have to pay close
to $9000,00 in fines, and forfeit
$425,000 in ill-gained profits.